FDA-Device2013-03-13Class II
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
Salyer Prn Biomedical
Hazard
Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.
Sold states
Distributed in the states of MA,CA, and WI.
Affected count
9 units
Manufactured in
1833 W Main St Ste 116, N/A, Mesa, AZ, United States
Products
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0902-2013Don't want to check this manually?
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